Aspetti normativi e medico legali in tema di usabilità dei dispositivi medici.

Today the issue of usability is increasingly relevant in Europe and thereby in Italy. It is necessary that devices are tested for "usability engineering" to assess the readiness and the safety of use. Regarding to the Medical Devices (MDs) is recommended the execution of specific tests to prevent adverse events related to an incorrect use. The Authors examine the current laws and recommendations concerning the MDs. The Authors also analyze the disputes arising from the unsafe MDs use: the Ministry of Health liability arising from the omissions in oversight; the health workers’ and physicians’ liability from not reporting a defect inMDs use; the hospital liability where is increasingly required, in the daily practice, to comply with protocols and recommendations. Then, is not far away the occurrence that in the event of damage arising from MDs should be required the proof that they meet the latest recommendations regarding usability.